Commentary on Fit-For-Purpose Models for Regulatory Applications.

Model-based analyses have been applied to influence various drug development and regulatory decisions in the last 2 decades. Applied models range from empirical models to highly complex mechanistic models. "Fit-for-purpose" has been the principle to determine the level of model complexity. While numerous case studies have been published to highlight the impact and value of model-based analyses, more experience and lessons are being accumulated to address new challenges and create more opportunities. The inclusion of Model-Informed Drug Development in the Prescription Drug User Fee Act (PDUFA) VI represents a new landmark for the field of quantitative clinical pharmacology.

Physiologically Based Pharmacokinetic Modeling in Regulatory Science: An Update From the U.S. Food and Drug Administration's Office of Clinical Pharmacology.

This commentary provides an update on the status of physiologically based pharmacokinetic modeling and simulation at the U.S. Food and Drug Administration's Office of Clinical Pharmacology. Limitations and knowledge gaps in integration of physiologically based pharmacokinetic approach to inform regulatory decision making, as well as the importance of scientific engagement with drug developers who intend to use this approach, are highlighted.

[Mild dementia and driving ability. Part 2: Assessment and its consequences in practice]. / Beginnende Demenz und Fahreignung. Teil 2: Das Assessment und seine praktischen Konsequenzen.

The legal framework and the essentials in traffic and transport psychology and statistics were described in part 1. Safe driving depends on different sensory and mental processes interacting in a complicated manner. Physiological changes and--even more importantly--a variety of diseases result in impaired performance in these functional areas. Moderate to severe dementia certainly means that the person is no longer fit to drive, whereas driving ability may be maintained in mild dementia for some time. There are different approaches and assessment tools, but a single test that could, on its own, answer the question whether a patient with mild dementia is fit to drive does not exist. Driving ability is not only determined by cognitive function. Further assessment of possible risk factors and overall functioning is necessary. If dementia is diagnosed, then the question of fitness to drive must be promptly discussed with the patient because during the course of dementia driving ability will inevitably be lost. The conclusion of the assessment of driving ability must not be pronounced like a verdict, the physician should rather counsel and support the patient and his family on the difficult road towards driving cessation.

Judicious use of simulation technology in continuing medical education.

Use of simulation-based training is fast becoming a vital source of experiential learning in medical education. Although simulation is a common tool for undergraduate and graduate medical education curricula, the utilization of simulation in continuing medical education (CME) is still an area of growth. As more CME programs turn to simulation to address their training needs, it is important to highlight concepts of simulation technology that can help to optimize learning outcomes. This article discusses the role of fidelity in medical simulation. It provides support from a cross section of simulation training domains for determining the appropriate levels of fidelity, and it offers guidelines for creating an optimal balance of skill practice and realism for efficient training outcomes. After defining fidelity, 3 dimensions of fidelity, drawn from the human factors literature, are discussed in terms of their relevance to medical simulation. From this, research-based guidelines are provided to inform CME providers regarding the use of simulation in CME training.

[Rhinoplasty: indication and planning]. / Rhinoplastik: Indikation und Planung.

A plethora of publications addresses surgical techniques in rhinoplasty, whereas substantially less has been published on psychological aspects and the planning of the procedure. This review covers the psychology of the rhinoplasty patient, risk factors for postoperative dissatisfaction, the surgeon-patient relationship, planning of the procedure using computer imaging and obtaining informed consent.

Government sanctioned "tight" and "loose" slot machines: how having multiple versions of the same slot machine game may impact problem gambling.

In Ontario, Canada, the regulator approves identical looking slot machine games with different payback percentages. We gained access to the design documents (called PAR Sheets) used to program these different versions of the same slots game and ran Gambler's Ruin simulations of 2,000 first-time players who each arrived with a $100 bankroll and played either the 85 or 98% version of the same game until broke. Simulations revealed that the typical (median) player's experience did not differ significantly between versions. However the payback percentage affected the experience of players in the upper tails of the distributions with those in the 98% version having dramatically more total spins, winning spins, entries into the "bonus mode", and "hand pays" (a win of $125 or more on a given spin). Most importantly, the number of simulated players who had a maximum peak balance in excess of $1,000 rose tenfold-from 5 in the 85% version to 54 in the 98% version. The results are discussed in terms of the Pathways Model of Problem and Pathological Gambling especially in terms of behavioural conditioning, cognitive beliefs, and early big wins. It may well be that those machines that are on the surface the "fairest" to the gambler, actually pose the most risk for ensuing gambling problems.

Protecting innovation in bioinformatics and in-silico biology.

Commercial success or failure of innovation in bioinformatics and in-silico biology requires the appropriate use of legal tools for protecting and exploiting intellectual property. These tools include patents, copyrights, trademarks, design rights, and limiting information in the form of 'trade secrets'. Potentially patentable components of bioinformatics programmes include lines of code, algorithms, data content, data structure and user interfaces. In both the US and the European Union, copyright protection is granted for software as a literary work, and most other major industrial countries have adopted similar rules. Nonetheless, the grant of software patents remains controversial and is being challenged in some countries. Current debate extends to aspects such as whether patents can claim not only the apparatus and methods but also the data signals and/or products, such as a CD-ROM, on which the programme is stored. The patentability of substances discovered using in-silico methods is a separate debate that is unlikely to be resolved in the near future.

New visual technologies in court: directions for research.

Litigation is being transformed by new visual communication technologies, including videoconferencing, PowerPoint, and computer animations. Yet the effects of these visual technologies on legal decision making are largely unknown. In order to understand better the most pressing issues surrounding technology in the courtroom, psychologists, lawyers, and representatives from technology companies and funding agencies attended a Research Conference on Courtroom Technology organized by the Federal Judicial Center. The goals of the conference were to identify issues raised by courtroom uses of new technologies that could be illuminated by empirical research and to suggest designs and methods for conducting that research. This paper emerged from that conference. The authors provide an overview of considerations that should guide research in this area, including a framework that takes into account features of the technology, the audience, and the legal strategy of the user of the technology. They outline a paradigm for conducting such research, illustrate it with several possible empirical studies of varying levels of experimental and conceptual complexity, and identify directions for subsequent research.

Calidad y simulaciones / Quality and simulation

No disponible

Advantages and disadvantages of computer imaging in cosmetic surgery.

BACKGROUND: Despite the growing popularity of computer imaging systems, it is not clear whether the medical and legal advantages of using such a system outweigh the disadvantages. OBJECTIVE: The purpose of this report is to evaluate these aspects, and provide some protective guidelines in the use of computer imaging in cosmetic surgery. METHODS: The positive and negative aspects of computer imaging from a medical and legal perspective are reviewed. Also, specific issues are examined by a legal panel. RESULTS: The greatest advantages are potential problem patient exclusion, and enhanced physician-patient communication. Disadvantages include cost, user learning curve, and potential liability. CONCLUSION: Careful use of computer imaging should actually reduce one's liability when all aspects are considered. Recommendations for such use and specific legal issues are discussed.